FDA 510(k) Application Details - K082132

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K082132
Device Name	Unit, Phacofragmentation
Applicant	BAUSCH & LOMB, INC 1400 North Goodman Street Rochester, NY 14609 US Other 510(k) Applications for this Company
Contact	NED LUCE Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2008
Decision Date	08/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review